The company’s submission provides information to the FDA on Prurisol supporting a pre-IND meeting.
With the meeting, Cellceutix intends for guidance to attain approval for a section 505(b)(2) designation for Prurisol from the FDA, allowing its proposed clinical trials to begin in advanced stages.
The aim of the meeting is to gain a full understanding of the studies required to support a New Drug Application (NDA) filing for Prurisol.
Cellceutix chief scientific officer Krishna Menon said because the safety and tolerability of the active ingredient have already been determined by the FDA, the company is hopeful that it will meet the requirements to advance immediately to Phase 2/3 clinical trials, saving considerable time and money.
"As part of our planned meeting with the FDA, we will also discuss Prurisol’s eligibility for ‘Fast Track’ review, a designation that will further expedite our efforts to bring Prurisol to market," Menon added.